Aspirin on CTCs of Advanced Breast and Colorectal Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

Study Completion Date

2017-02-28

Brief Summary

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The purpose of this study is to determine whether Aspirin could affect the number and subtype of circulating tumor cells of metastatic breast cancer and colorectal cancer.

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Detailed Description

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BACKGROUND:

* Invasion and metastasis are the main reason of death in metastatic cancer, and abundant evidence find circulating tumor cells(CTCs) take the core position in breast and colorectal cancer metastasis.
* Platelets play multiple role to facilitate the epithelial to mesenchymal transition of tumor cells and protect CTCs to survival in the circulation, which enrolled in the whole process of metastasis.
* Several clinical trials and observational study have validate the primary and secondary prevention effect of aspirin to both breast and colorectal cancer.

OBJECTIVES:

* Determine the effect of aspirin on CTC number of metastatic breast and colorectal cancer;
* Determine the effect of aspirin on CTC subtype (epithelial/mesenchymal/mixed type) of metastatic breast and colorectal cancer.

ELIGIBILITY:

* Adults age from 18-75 years old.
* Patients were diagnosed for metastatic breast or colorectal cancer by pathology.
* Patients who were not currently receiving intravenous chemotherapy , oral administrated with capecitabine was permitted. Concurrent endocrine therapy ( for at least 2 months before enrollment), bisphosphonate therapy, and/or monoclonal targeted therapy were permitted.
* No disease of hemorrhagic tendency or history of non-steroid drug allergy.
* CTCs≥5 / 7.5ml blood

STUDY DESIGN:

* Aspirin will be administered orally once a day in 28-day cycles.
* The CTC was evaluated every 28 days for 2 months.

Conditions

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Epithelial-Mesenchymal Transition Circulating Tumor Cells

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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aspirin

* The included patients will be administered with aspirin (100mg) orally once a day in 28-day cycles.
* The CTC was evaluated at baseline, and every 28 days for 2 months.

Group Type EXPERIMENTAL

Aspirin

Intervention Type DRUG

Take aspirin (100mg) orally once a day for 2 months

Interventions

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Aspirin

Take aspirin (100mg) orally once a day for 2 months

Intervention Type DRUG

Other Intervention Names

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acetylsalicylic acid

Eligibility Criteria

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Inclusion Criteria

* Adults age from 18-75 years old.
* Patients were diagnosed for metastatic breast or colorectal cancer by pathology.
* Patients who were not currently receiving intravenous chemotherapy , oral administrated with capecitabine was permitted.
* Concurrent endocrine therapy ( for at least 2 months before enrollment), bisphosphonate therapy, and/or monoclonal targeted therapy were permitted.
* PS score ≤ 3
* Anticipated survival time ≥ 3 months
* CTCs≥5 / 7.5ml blood

Exclusion Criteria

* Allergic to aspirin or other types of non-steroid
* History of hemorrhage of digestive tract or other hemorrhagic disease
* Plan to receive surgery within the time frame of the trial
* Medication history of aspirin or other types of anti-platelets drug within one months before the trial
* Women in pregnant or lactation period
* Any psychological or objective problem may influence the compliance of the patients

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No